Biotech Allegro Single Use System Reach
Biotech Allegro Single Use System Reach
Biotech Allegro Single Use System Reach
Pall’s Allegro single-use systems (SUS) are considered ‘complex objects’ comprised of
‘component articles’ under the REACH regulations. These products do not contain
authorized substances found in Annex XIV (‘List of substances subject to authorisation’)
nor any substances subject to Annex XVII restrictions (‘Restrictions’).
Siloxanes
Allegro SUS may include one or more silicone components containing the following
candidate listed SVHCs above 0.1% by weight.
Lead
Allegro SUS may incorporate sensors where the supplier has advised that lead is present
above 0.1% by weight.
Hydrogenated Terphenyl
Allegro SUS may incorporate sensors where the supplier has advised that Hydrogenated
Terphenyl is present above 0.1% by weight.
Please be advised that in line with the requirements of Waste Framework Directive
2008/98/EC Article 9(1)(i) as amended by 2018/851/EU, the component articles and the
complex objects using these components are listed in the ECHA database for Substances
of Concern in Products (‘SCIP’).
All Allegro SUS labels include a link to this regulatory letter for notification and
information purposes.
© Copyright 2023, Pall Corporation, Pall, , Allegro, and Kleenpak are trademarks of Pall Corporation. All rights reserved. ® Indicates a trademark
registered in the USA.
Addendum 1 to this letter contains a listing of the ECHA SCIP database entry numbers
made by Pall Corporation alongside a description of the applicable component articles in
the “Primary Article Identifier” field of SCIP. To check if your specific Allegro single-use
system part number is covered by an entry, please consult the field marked “Other article
Identifier” within the ECHA SCIP database, where the impacted Allegro single-use system
part numbers (subject to that entry) have been listed. Alternatively, you can consult your
Allegro single-use system drawing(s) for the component part numbers used in that
system(s).
Addendum 2 to this letter contains a listing of all component part numbers which have
been entered into the ECHA SCIP database. Please note that Addendum 2 is complete as
of the date of this letter but is subject to continuous review as new supplier information is
received or new components require additional entries into the ECHA SCIP database. We
will update this letter on a periodic basis, but you should consider the ECHA SCIP
database as the primary and most up-to-date source of information.
To the best of our knowledge this information is accurate as of the date of issuance.
However, these statements are subject to change as new information becomes available.
We recommend that you periodically confirm this information.
Addendum 1:
Pall Corporation SCIP entry tracker